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Phase II Study for Robot Assisted Distal Gastrectomy (RADGphaseII)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Masanori Terashima, Shizuoka Cancer Center
ClinicalTrials.gov Identifier:
NCT01504997
First received: December 30, 2011
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

The aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph node dissection in patients with stage Ia early gastric cancer.


Condition Intervention Phase
Early Gastric Cancer
 Device: Robot assisted distal gastrectomy (DaVinci)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shizuoka Cancer Center:

Primary Outcome Measures:
  • The incidence of post-operative intra-abdominal infectious complications [ Time Frame: Participants will be followed for the duratin of hospital stay, an expected average of 10 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Relapse free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Completion rate of robot assisted surgery [ Time Frame: During the surgery, an expected average of 5 hours ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 23
Study Start Date: December 2011
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robot assisted distal gastrectomy
patients who received robot assisted distal gastrectomy
 Device: Robot assisted distal gastrectomy (DaVinci)
patients who received robot assisted distal gastrectomy
Other Name: DaVinci

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biopsy specimen from the primary lesion shows adenocarcinoma
  2. Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography
  3. Endoscopic submucosal dissection is not indicated
  4. Tumor was located within lower two thirds of stomach
  5. Not having duodenal invasion
  6. Eastern clinical oncology group performance status is 0 or 1
  7. Body mass index is lower than 30
  8. No prior laparotomy
  9. No prior chemotherapy or radiation including those for other cancers
  10. Fulfil all following conditions WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT < 100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl

Exclusion Criteria:

  1. Having other active cancers
  2. Possibly pregnant, or breast feeding woman
  3. with psychiatric disorder
  4. Receiving steroids
  5. With Acute myocardial infarction in 6 months or with unstable angina
  6. With uncontrolled hypertension
  7. With uncontrolled diabetes mellitus
  8. With pulmonary disease which require continuous oxygen therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504997

Locations
Japan
Shizuoka Cancer Center
Shizuoka, Japan, 411-0934
Sponsors and Collaborators
Shizuoka Cancer Center
Investigators
Principal Investigator: Masanori Terashima, M.D., Ph.D. Division of Gastric Surgery, Shizuoka Cancer Center
  More Information

No publications provided

Responsible Party: Masanori Terashima, Head of Gastric Surgery, Shizuoka Cancer Center
ClinicalTrials.gov Identifier: NCT01504997     History of Changes
Other Study ID Numbers: DaVinci_SCC, UMIN000006910
Study First Received: December 30, 2011
Last Updated: January 9, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Shizuoka Cancer Center:
DaVinci
Robot assisted surgery
Gastrectomy
Safety
Gastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on June 17, 2013